BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇦 Canada

    GLUSITE, MODEL GLU002

    K Number: K013446 · Decision Dec 20, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    144
    Registration Numbers
    144
    Same Product Code
    504
    Applicant Total
    5
    Review Days
    64

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    Basic Information

    Device Name
    GLUSITE, MODEL GLU002
    K Number
    K013446
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3275
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Glustitch, Inc.
    Date Received
    October 17, 2001
    Decision Date
    December 20, 2001
    Product Code
    EMA
    Advisory Committee
    Dental
    Review Advisory Committee
    DE
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    EMA Cement, Dental

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